Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019798
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NASACORT TRIAMCINOLONE ACETONIDE 0.055MG/INH AEROSOL, METERED;NASAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/11/1991 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/17/2000 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1997 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/02/1996 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/20/1996 SUPPL-6 Efficacy-New Indication

Label is not available on this site.

11/21/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/06/1994 SUPPL-2 Labeling

Label is not available on this site.

11/30/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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